Last updated: June 3, 2026
Aggrastat suppliers: manufacturers, sourcing risks, and downstream procurement
Executive summary: Aggrastat is tirofiban hydrochloride (antiplatelet; GP IIb/IIIa inhibitor). Key supply sources are tied to the branded product’s NDC/labeler and to upstream active pharmaceutical ingredient (API) and sterile fill-finish capacity. Aggrastat procurement should be organized around (1) the labeled product manufacturer supplying the vial and carton channel, (2) the API manufacturer(s) supporting tirofiban HCl, and (3) the sterile manufacturing sites performing drug product fill-finish under NDA/ANDA controls.
Who manufactures Aggrastat (tirofiban) in the US market?
Short answer: Aggrastat is marketed as a sterile parenteral product, and the most decision-relevant “supplier” for procurement is the NDA labeler listed on the FDA NDC directory for each strength and package configuration.
How to identify the correct supplier for purchasing
- Pull the NDC for the exact presentation (strength, vial size, pack count).
- Match the NDC labeler to the drug product manufacturer responsible for commercial release.
- For tendering and continuity, track:
- Current labeler
- site(s) of manufacture referenced in the label/CMC documentation
- distribution continuity via lot history and lead-time consistency
What changes the “supplier” in practice
- Labeler changes (marketing rights, re-labeling, or distribution redesign)
- Contract manufacturing shifts (sterile fill-finish transfers)
- API sourcing substitutions during market shortages
What companies supply the tirofiban hydrochloride API for Aggrastat?
Short answer: Upstream suppliers for tirofiban hydrochloride are typically disclosed via regulatory filings (NDA/CMC) and supplier qualification documentation. For procurement, API sourcing is still the most material constraint because it drives lead time and shortage risk for sterile products.
API supply chain structure
- Tiropfiban HCl API manufacturer (chemical synthesis)
- API testing and release (COA matching per batch)
- Drug substance storage and traceability into sterile manufacturing
Key procurement due diligence points
- Alternate API sources allowed by the approved manufacturing process
- Regulatory status of substitutes (whether changes require reporting vs. supplements)
- Impurity profile control strategy for tirofiban HCl batches
Which contract manufacturers do sterile fill-finish for Aggrastat?
Short answer: The sterile product supplier is the fill-finish manufacturer listed for the NDA product. Aggrastat is a sterile injection presentation, so the relevant manufacturing risk sits in:
- compounding
- sterile filtration/fill
- terminal sterilization (if applicable to the specific presentation)
- packaging and release testing
Fill-finish constraints that affect supply
- vial line capacity and sterile grade utilities
- human factors for aseptic processing
- environmental monitoring system performance
- batch release turnaround for sterility/particulate assays
How do hospital purchasing and GPO contracts define “supplier” for Aggrastat?
Short answer: Hospitals usually treat the contract distributor/vendor as the supplier, but the continuity risk comes from the NDA labeler and manufacturing site behind that distributor.
Operational definitions
- Contract supplier (GPO/distributor): ships product, provides pricing and inventory visibility
- Market supplier (NDC labeler/manufacturer): controls commercial release and batch availability
- Supply chain bottleneck: API availability or sterile fill-finish capacity
What is the Orange Book status of Aggrastat and how does it affect sourcing?
Short answer: Aggrastat is a prescription sterile product with an established branded supply chain; generic and related products can change sourcing competition. Orange Book status impacts whether multiple labelers compete for procurement contracts.
Procurement implication
- If there are multiple FDA-approved equivalents, hospitals can diversify supply.
- If the market has limited approved products for the exact presentation, procurement becomes labeler- and manufacturer-dependent.
How many suppliers exist for Aggrastat (product-level and chain-level)?
Short answer: The number of true suppliers depends on:
- how many NDC labelers are active for each presentation
- whether labelers share the same sterile fill-finish site
- whether multiple API manufacturers support tirofiban HCl supply
What to count in a supplier landscape
| Supplier layer |
Count method |
Why it matters |
| NDC labeler (drug product) |
FDA NDC labeler per strength/presentation |
Controls drug product release and contract availability |
| Sterile fill-finish site |
Label/CMC references and lot documentation |
Drives sterile manufacturing continuity |
| API manufacturer |
NDA/CMC and qualification docs |
Drives upstream lead time and shortage risk |
What are the main risks to Aggrastat supply continuity?
Short answer: For sterile tirofiban injection, the dominant risks are sterile manufacturing capacity, API batch availability, and regulatory batch release timelines.
Risk categories
- API availability constraints for tirofiban HCl
- Sterile facility downtime, deviations, or remediation cycles
- Release delays from sterility/particulate testing and trending
- Transportation and cold chain are usually not the constraint for this class, but packaging integrity and lead-time volatility can be
What supplier substitutions are feasible during a shortage for Aggrastat?
Short answer: Substitution options depend on whether procurement is:
- between different labelers (same drug, same strength, same presentation)
- between different presentation (vial size or formulation differences)
- between branded vs. generic equivalents (if FDA approvals exist)
What to confirm for switchovers
- identical NDC or equivalent presentation
- matching dosing concentration and infusion compatibility
- hospital protocol alignment and procurement contract terms
Key Takeaways
- “Supplier” for Aggrastat should be tracked at three levels: NDC labeler, sterile fill-finish site, and tirofiban HCl API manufacturer.
- Procurement resilience comes from confirming alternate labelers and validating alternate supply paths (API and fill-finish).
- Supply disruption risk is most likely to originate from API batch availability or sterile manufacturing capacity and release testing rather than distribution.
FAQs
- What NDC labeler should pharmacies stock for Aggrastat to match the hospital formulary?
- Can Aggrastat be substituted with a different tirofiban hydrochloride presentation during a shortage?
- What documentation should procurement require to qualify alternate Aggrastat lots from a different labeler?
- How do sterile fill-finish site changes affect batch release timelines for tirofiban injection?
- Does Aggrastat’s supplier landscape differ for single-vial vs multi-pack procurement?
References (APA)
- FDA. (n.d.). NDC Directory. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
- FDA. (n.d.). Drugs@FDA. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
